Senior Regulatory Affairs Specialist – Greater Asia

Job description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Summary Join Baxter’s Regulatory Affairs team and make a direct impact on how innovative medical devices reach patients safely across Greater Asia. In this role, you’ll design and implement regulatory strategies, secure product approvals, and ensure compliance with evolving requirements. You’ll be hands‑on in shaping Baxter’s portfolio, working across new product development, post‑market activities, and regional projects—all while building your expertise and influence in a dynamic healthcare environment. What You’ll Do Apply your medical device experience to drive regulatory success. Develop and execute project plans that keep approvals on track. Identify and escalate regulatory risks early, ensuring proactive solutions. Stay ahead of international regulatory requirements and translate them into clear, actionable steps. Be an active contributor on project teams, offering practical regulatory advice. Respond to regulatory authority inquiries within strict timelines. Compile, prepare, and submit registrations, renewals, variations, and change notifications to secure timely approvals. Review and approve labeling and promotional materials for compliance. Represent Regulatory Affairs in project teams, supporting business objectives and compliance standards. Manage post‑market surveillance, field actions, and complaints in Singapore and Malaysia. Own regulatory databases and reporting, ensuring accuracy and transparency. Share regulatory intelligence with business units, strengthening collaboration and decision‑making. Support continuous improvement initiatives, including process optimization and digitization. Participate in audits and ensure documentation control, GDP compliance, and record retention. Take on additional responsibilities that broaden your expertise and support regulatory excellence. What You’ll Bring A degree in Pharmacy, Health Sciences, or equivalent. Minimum 5 years of regulatory experience in medical devices. Proven expertise in new registrations, license extensions, variations, and renewals, with mandatory experience in Class II devices and above. Strong knowledge of regulatory laws, acts, and evolving requirements. Solid understanding of GDPMD standards. Skills in project management, multitasking, and prioritization. Excellent interpersonal, communication, and negotiation abilities. Proficiency in technical systems (word processing, spreadsheets, databases, online research). Ability to identify compliance risks and escalate effectively. Experience with RIM systems is an advantage. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .